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Recruiting Phase 1, Phase 2 NCT06597695

A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression

Trial Parameters

Condition Depression
Sponsor Juliana Zambrano, MD, MPH
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 10
Sex ALL
Min Age 18 Years
Max Age 64 Years
Start Date 2025-07-23
Completion 2026-07-01
Interventions
Ketamine-assisted psychotherapy

Brief Summary

This is a pilot clinical trial to assess the feasibility, safety, and preliminary efficacy of ketamine-assisted group therapy for Spanish-speaking adults with depression

Eligibility Criteria

Inclusion Criteria: 1\. Self-identifying Latinx, Spanish-speaking 2. Adults 18-64 years 3. Meet DSM-5 criteria for major depressive disorder as evaluated by study clinician 4. Montgomery-Asberg depression scale (MADRS) score of 20 or above at baseline 4. Participants must have an MGB psychiatrist and primary care provider. Exclusion Criteria: 1. History of primary psychotic disorder, by history 2. History Bipolar I disorder, by history 3. Unstable complex PTSD, as assessed by study clinician 4. History of dissociative identity disorder 5. History of neurocognitive disorder 6. History of severe and/or recent substance use disorder, by history and as assessed by study clinician after clinical evaluation and interview 7. Uncontrolled hypertension, tachycardia, or unstable cardiopulmonary disease, by history a. Blood pressure on initial screen must be \<140/90 mmHg. 8. History of aortic dissection 9. History of myocardial infarction 10. History of aneurysm 11. History of hepatic impairment

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